Lifestyle Intervention for Patients With Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT05402501
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.

Detailed Description

This study aims to investigate the effect of an online lifestyle program on the impact of multiple sclerosis (MS) on daily functioning. MS patients will participate in the online lifestyle intervention of Voeding Leeft and will complete online questionnaires at 7 time-points: 3 months before the start of the intervention (run-in), before the start of the intervention (baseline), and 3, 6, 12, 18 and 24 months after the start of the intervention. A subsample (n=200) will also take part in measurements through mobile applications. The investigators hypothesize that the lifestyle program will reduce the impact of MS on the patients' daily functioning.

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2022-04-19
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-30
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• MS diagnosis
• Motivated to adapt their lifestyle
• Able to complete online questionnaires by themselves
• Able to do grocery shopping and to (let someone) prepare the meals from the program
• In a subpopulation (n=200): daily use of a smartphone

Exclusion Criteria

• Not able to participate in an online lifestyle intervention (e.g. not having an email address, laptop/computer, internet)
• An inability to speak or read Dutch
• Vegan diet
• Not willing to eat fish
• BMI <18.5 and >35 kg/m2
• Pregnant or breastfeeding
• Diagnosis of an eating disorder or psychiatric disorder (according to the DSM-V criteria)
• History of bariatric surgery
• Another disorder, such as inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), cardiovascular disease (e.g. severe heart failure), malignancy, diabetes type 1 and 2
• Having previously participated in a lifestyle intervention of Voeding Leeft or currently participating in another lifestyle program or lifestyle study.
• Currently under treatment at a dietician or lifestyle coach

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple Sclerosis Impact Scale (MSIS-29)	Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures the impact of MS on their daily functioning

Secondary Outcome Measures

Name	Time	Method
Bristol stool chart	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Tool used to indicate stool type
MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT)	Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Only in a subsample (n=200); Patients will use the MS sherpa app to perform a smartphone-adapted Symbol Digit Modalities Test (sSDMT) on their mobile phone.
BMI	Assessed at 7 time-points during 27 months Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	BMI in kg/m\^2
Hospital Anxiety and Depression Scale (HADS)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures symptoms of depression and anxiety
Perceived stress scale (PSS)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures the level of perceived stress
EuroQol 5 Dimensions Questionnaire (EQ-5D)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures quality of life
Waist circumference	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Waist circumference in centimeters
Medical Consumption Questionnaire (iMCQ)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures health-care consumption
MS sherpa app - Smartphone-adapted two-minute walking test	Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Only in a subsample (n=200); Patients will use the MS sherpa app to perform a two-minute walking test outside.
12-item Short Form Health Survey (SF-12)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures quality of life
Checklist Individual Strength-20-r (CIS-20)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures the level of fatigue
Medical Outcomes Study Sleep Scale (MOS-ss)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures sleep quality
Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures the level of subjective cognitive complaints
Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB))	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures the level of physical activity
iMTA Productivity Cost Questionnaire (iPCQ)	Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Questionnaire that measures work productivity and the frequency of sick leave
Neurokeys keyboard app	Continuous measures during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology.
MS sherpa app - questionnaire	Weekly questionnaire during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.	Only in a subsample (n=200); Patients will use the MS sherpa app to answer seven questions on a likert-scale (e.g. about pain, stress, energy, memory) within the mobile application.

Trial Locations

Locations (1)

Amsterdam UMC, location VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands